HIV InfectionsSmartLtCNCT02756949
Smart Linkage-to-HIV Care Via a Smartphone App
A study testing Smartphone application and Smartphone in people with HIV Infections and Viral Load, run by World Bank at 1 site in South Africa.
Trial summary
This randomized controlled trial evaluates the provision of individual patient laboratory results to newly diagnosed HIV positive smartphone users through a secure application (app) as a method to get them linked to and retained in care, and engage with educational materials purposefully developed to explain their… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Viral Load, Patient Compliance
- What is being tested?
- Smartphone application and Smartphone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 353 participants
- Where
- 1 siteSouth Africa
- Study dates
- Oct 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed HIV positive clients presenting at selected public health facilities, irrespective of CD4 count
- Access to an Android smartphone with data
- Willing to pay the (very small) cost to access their laboratory result
- Age - 18 years and older
- Proof of ID/passport/refugee number (for identification/security, and to confirm the single patient identifier)
- Can read English or Zulu
- Ability and willingness to sign informed consent
Who cannot join
- Clients presenting for antenatal care services, as these women will be enrolled in the national MomConnect program
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Wits Reproductive Health and HIV Institute
Johannesburg, Gauteng, 2001
About this study
Official title: Do Smartphones Increase Linkage to and Retention in Care in Newly Diagnosed HIV-positive Patients in Johannesburg, South Africa: A Multisite Randomised Controlled Trial
This randomized controlled trial evaluates the provision of individual patient laboratory results to newly diagnosed HIV positive smartphone users through a secure application (app) as a method to get them linked to and retained in care, and engage with educational materials purposefully developed to explain their results. Message prompts will also be used to alert patients that their results are ready and provide information on how to link to care, and assistance to re-link to care if they fall out of the health system for any reason. Prompts will be sent to patients to remind health care workers if they are due for repeat laboratory monitoring. The primary endpoint is linkage to care (a HIV-related laboratory test) at 6 months. The control group received standard of care.
Read the detailed description
This evaluation of a newly designed smartphone application (app) for linkage to care, HIV treatment adherence and retention in care, is taking place at five Johannesburg health facilities. Intervention allocation is random with individuals either receiving the smartphone app or standard of care. The trial is motivated by evidence from elsewhere that sending lab results via app acceptable, and loss of patients in need of HIV care can be reduced with mobile Health interventions. There is a growing number of smartphones in South Africa (at the time of baseline assessment, about 40% of the surveyed population had an Android smartphone with data, and the majority of new phones are smartphones). The trial's objectives are: a) Test whether routine linkage to HIV care at public sector services is improved by providing HIV positive clients with a smartphone-enabled app when compared to standard of care; b) Determine HIV treatment initiation rates between intervention and control arm; c) Test the feasibility and acceptability of receiving lab results via app; d) Assess secondary effects from improved participant information, including return rates after falling out of care, participant satisfaction, and rates of repeat blood tests; e) Determine knowledge levels on HIV care; and f) Assess the effect in priority groups for better linkage to care (male HIV cases and HIV positive youth). If data allow, a cost-benefit analysis will also be conducted.
- Being tested
- Smartphone application, Smartphone
- Keywords
- HIV, Viral load, CD4 count, mHealth, Smartphone, Linkage to care, Retention in care, Antiretroviral treatment, Randomized controlled trial, Johannesburg, Mobile app, Treatment adherence
- Medical subject headings
- HIV Infections, Patient Compliance, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone applicationOther
Also called App, Customised smartphone app
Laboratory result data will be presented in the app with simple explanations on every screen. English and Zulu languages will be offered in the same app and written at a grade 4 reading level (as per WHO guidelines on literacy). Laboratory results will be supplemented with informative and relevant information explaining the result that has been shown and the recommended action for the patient to take. Patients will also be able to view additional HIV-related information and a Frequently Asked Questions (FAQ) through the app.
SmartphoneDevice
| Study group | Role | What they receive |
|---|---|---|
| Smartphone-enabled app for linkage to care | Experimental | Participants in this arm are randomised to receive the smartphone application which provides direct access to HIV-related laboratory test results. Receives: Other: Smartphone application; Device: Smartphone |
| Standard of care | No intervention | Participants in this arm are randomised to receive standard of care services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months)
To test whether linkage to HIV care is improved by providing new HIV clients with access to a smartphone-enabled application (app) when compared to standard of care around 6 months post-diagnosis.
Measured: Recruitment +8 months
Secondary outcomes (1)
Linkage to HIV Care Among Young People (Indicated by a HIV-related Laboratory Blood Test Within 8 Months)
To test whether among individuals aged 18-30 years linkage to HIV care is improved by providing new HIV clients with access to a smartphone-enabled application (app) when compared to standard of care around 6 months post-diagnosis.
Measured: Recruitment +8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startOct 2015
- Primary completionFeb 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- World Bank
- Sponsor type
- University, hospital or other
- Collaborators
- Wits Reproductive Health and HIV Institute, National Health Laboratory Service South Africa, Department for International Development, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Francois Venter, Prof, Study director, Wits Reproductive Health and HIV Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756949
- Sponsor's protocol ID
- 7173708
- Acronym
- SmartLtC
- Status last verified
- Apr 2019
- First submitted
- 27 Apr 2016
- Last updated
- 24 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Venter WDF, Fischer A, Lalla-Edward ST, Coleman J, Lau Chan V, Shubber Z, Phatsoane M, Gorgens M, Stewart-Isherwood L, Carmona S, Fraser-Hurt N. Improving Linkage to and Retention in Care in Newly Diagnosed HIV-Positive Patients Using Smartphones in South Africa: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Apr 2;7(4):e12652. doi: 10.2196/12652.
PubMed 30938681Venter W, Coleman J, Chan VL, Shubber Z, Phatsoane M, Gorgens M, Stewart-Isherwood L, Carmona S, Fraser-Hurt N. Improving Linkage to HIV Care Through Mobile Phone Apps: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Jul 17;6(7):e155. doi: 10.2196/mhealth.8376.
PubMed 30021706Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
PubMed 32779730
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Smartphones Increase Linkage to and Retention in Care in Newly Diagnosed HIV-positive Patients in Johannesburg, South Africa: A Multisite Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02756949
- Acronym / sponsor ID
- SmartLtC / 7173708
- Keywords
- HIV, Viral load, CD4 count, mHealth, Smartphone, Linkage to care, Retention in care, Antiretroviral treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- World BankUniversity, hospital or other
- Collaborators
- Wits Reproductive Health and HIV Institute, National Health Laboratory Service South Africa, Department for International Development, United Kingdom
- Study start
- Oct 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Posted 24 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial evaluates the provision of individual patient laboratory results to newly diagnosed HIV positive smartphone users through a secure application (app) as a method to get them linked to and retained in care, and engage with educational materials purposefully developed to explain their results. Message prompts will also be used to alert patients that their results are ready and provide information on how to link to care, and assistance to re-link to care if they fall out of the health system for any reason. Prompts will be sent to patients to remind health care workers if they are due for repeat laboratory monitoring. The primary endpoint is linkage to care (a HIV-related laboratory test) at 6 months. The control group received standard of care.
Detailed description
This evaluation of a newly designed smartphone application (app) for linkage to care, HIV treatment adherence and retention in care, is taking place at five Johannesburg health facilities. Intervention allocation is random with individuals either receiving the smartphone app or standard of care. The trial is motivated by evidence from elsewhere that sending lab results via app acceptable, and loss of patients in need of HIV care can be reduced with mobile Health interventions. There is a growing number of smartphones in South Africa (at the time of baseline assessment, about 40% of the surveyed population had an Android smartphone with data, and the majority of new phones are smartphones). The trial's objectives are: a) Test whether routine linkage to HIV care at public sector services is improved by providing HIV positive clients with a smartphone-enabled app when compared to standard of care; b) Determine HIV treatment initiation rates between intervention and control arm; c) Test the feasibility and acceptability of receiving lab results via app; d) Assess secondary effects from improved participant information, including return rates after falling out of care, participant satisfaction, and rates of repeat blood tests; e) Determine knowledge levels on HIV care; and f) Assess the effect in priority groups for better linkage to care (male HIV cases and HIV positive youth). If data allow, a cost-benefit analysis will also be conducted.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone-enabled app for linkage to care | Experimental | Other: Smartphone application, Device: SmartphoneParticipants in this arm are randomised to receive the smartphone application which provides direct access to HIV-related laboratory test results. |
| Standard of care | No intervention | –Participants in this arm are randomised to receive standard of care services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Newly diagnosed HIV positive clients presenting at selected public health facilities, irrespective of CD4 count
- Access to an Android smartphone with data
- Willing to pay the (very small) cost to access their laboratory result
- Age - 18 years and older
- Proof of ID/passport/refugee number (for identification/security, and to confirm the single patient identifier)
Key exclusion criteria (2 listed)
- Clients presenting for antenatal care services, as these women will be enrolled in the national MomConnect program
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone applicationAlso: App, Customised smartphone appLaboratory result data will be presented in the app with simple explanations on every screen. English and Zulu languages will be offered in the same app and written at a grade 4 reading level (as per WHO guidelines on literacy). Laboratory results will be supplemented with informative and relevant information explaining the result that has been shown and the recommended action for the patient to take. Patients will also be able to view additional HIV-related information and a Frequently Asked Questions (FAQ) through the app. | Other | Smartphone-enabled app for linkage to care |
| Smartphone | Device | Smartphone-enabled app for linkage to care |
Primary outcome
Linkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months)
Time frame: Recruitment +8 months
To test whether linkage to HIV care is improved by providing new HIV clients with access to a smartphone-enabled application (app) when compared to standard of care around 6 months post-diagnosis.
1 secondary outcome
Linkage to HIV Care Among Young People (Indicated by a HIV-related Laboratory Blood Test Within 8 Months)
Time frame: Recruitment +8 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30938681Venter WDF, Fischer A, Lalla-Edward ST, Coleman J, Lau Chan V, Shubber Z, Phatsoane M, Gorgens M, Stewart-Isherwood L, Carmona S, Fraser-Hurt N. Improving Linkage to and Retention in Care in Newly Diagnosed HIV-Positive Patients Using Smartphones in South Africa: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Apr 2;7(4):e12652. doi: 10.2196/12652.
- Results publication: PubMed 30021706Venter W, Coleman J, Chan VL, Shubber Z, Phatsoane M, Gorgens M, Stewart-Isherwood L, Carmona S, Fraser-Hurt N. Improving Linkage to HIV Care Through Mobile Phone Apps: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Jul 17;6(7):e155. doi: 10.2196/mhealth.8376.
- Derived from this study: PubMed 32779730Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
- Smart Linkage to Care : Evaluation ReportLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois Venter, Prof study director
Wits Reproductive Health and HIV Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone application and Smartphone in people with HIV Infections and Viral Load, run by World Bank at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months) (time frame: Recruitment +8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02756949, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2019.